Job Title: Quality EngineerJob Description We are seeking a dedicated and skilled Quality Engineer with a Bachelor’s degree in Engineering, science, or a related field. The ideal candidate will have multiple years of engineering experience, preferably within a manufacturing environment. Experience in an FDA-regulated setting is preferred. This role requires a strong self-starter who can work independently as well as collaboratively within a cross-functional team. The candidate must demonstrate the ability to perform technical Non-Conformance Investigations and Root Cause Analyses. Responsibilities + Facilitate and maintain validation project documentation, including the Site Validation Master Plan. + Serve as the database administrator for Infinity QS (Statistical Process Control) software. + Provide statistical analysis support for manufacturing, new product development (NPD), trials, and validation activities. + Develop Standard Operating Procedures (SOPs) related to validation and risk management. + Monitor and prepare Key Performance Indicators (KPIs) for major customers. + Conduct quality and engineering studies to support manufacturing operations. + Facilitate Corrective Action / Preventive Action (CAPA) activities to identify and resolve root cause issues through sound investigation and effective problem-solving techniques within the manufacturing plant. + Train associates on quality topics required for their positions, including SPC and CAPA. + Coordinate continuous improvement initiatives alongside internal and external representatives. + Demonstrate commitment to the company’s values of Renew, Respect, Integrity, Teamwork, and Excellence. + Ensure all work is performed in a safe manner, contributing to the overall safety of the workplace. + Contribute to a cooperative working effort by demonstrating a willingness to perform other job-related tasks as needed or requested. Essential Skills + Bachelor’s degree in Engineering, science, or related field. + Multiple years of engineering experience in a manufacturing environment. + Experience in an FDA-regulated environment. + Ability to perform technical Non-Conformance Investigations and Root Cause Analyses. + Familiarity with statistical analysis and SPC software, especially Infinity QS. Additional Skills & Qualifications + Validation experience. + Exposure to Code Regulations such as CFR 210 and/or 211 (Pharma/FDA standards for manufacturing) and Medical Device Code 280. Work Environment This role operates within a manufacturing environment. The successful candidate will be expected to work standard business hours with occasional requirements for overtime based on project needs. The dress code is business casual, and adherence to safety protocols is mandatory. The role involves regular interaction with cross-functional teams and requires effective communication and collaboration skills. Pay and Benefits The pay range for this position is $30.00 - $40.00/hr. Eligibility requirements apply to some benefits and may depend on your job classification and length of employment. Benefits are subject to change and may be subject to specific elections, plan, or program terms. If eligible, the benefits available for this temporary role may include the following: • Medical, dental & vision • Critical Illness, Accident, and Hospital • 401(k) Retirement Plan – Pre-tax and Roth post-tax contributions available • Life Insurance (Voluntary Life & AD&D for the employee and dependents) • Short and long-term disability • Health Spending Account (HSA) • Transportation benefits • Employee Assistance Program • Time Off/Leave (PTO, Vacation or Sick Leave) Workplace Type This is a fully onsite position in Morristown,TN. Application Deadline This position is anticipated to close on Feb 3, 2025. About Actalent Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500. Diversity, Equity & Inclusion At Actalent, diversity and inclusion are a bridge towards the equity and success of our people. DE&I are embedded into our culture through: + Hiring diverse talent + Maintaining an inclusive environment through persistent self-reflection + Building a culture of care, engagement, and recognition with clear outcomes + Ensuring growth opportunities for our people The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law. If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing process due to a disability, please email actalentaccommodation@actalentservices.com (%20actalentaccommodation@actalentservices.com) for other accommodation options.